Brief summary:

BioFreedom Stemi Registry is a prospective, multicenter, fully observational post market registry designed to enroll 1000 STEMI patients at 15 centers in 7 Asian countries where the BioFreedom™ BA9™ (SS) DCS is available for clinical use. All enrolled patients will be followed up for 1 year.

Primary endpoints

Target Lesion Failure (TLF) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions)

CERC Asia Services

  • Project Management
  • Site Start-up
  • Regulatory Submissions
  • Contracts and payments Management
  • Monitoring
  • Safety Annual Reporting
  • Organization of CEC

CERC Services :

      • Data Management/EDC
      • Corelab (Events)



Hong Kong, Malaysia, Singapore, South Korea, Taiwan, Thailand, Vietnam

Center number : 15 centers + 2 satellite sites

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